A Study to Assess the Effect of Montelukast Sodium With Concomitant Administration of Inhaled Budesonide in Asthmatic Patients.

This study has been completed.

First Received on August 30, 2005. Last Updated on November 24, 2009 History of Changes

Sponsor:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00140946

Purpose

A study to assess the clinical effect of montelukast sodium with concomitant administration of inhaled budesonide in asthmatic patients.

Condition	Intervention	Phase
Asthma	Drug: MK0476; montelukast sodium/Duration of Treatment: 16 weeks Drug: Comparator: placebo / Duration of Treatment: 16 weeks	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	A Multicenter, Randomized, Placebo-Controlled, Double-Blind, Two-Period, Parallel-group Study to Assess the Effect of Montelukast Sodium With Concomitant Administration of Inhaled Budesonide in Asthmatic Patients.

Resource links provided by NLM:

MedlinePlus related topics: Asthma

Drug Information available for: Budesonide Montelukast sodium Montelukast

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

Percentage of days of asthma exacerbations

Secondary Outcome Measures:

Percentage of asthma free days
Percentage of nocturnal awakenings
Beta agonist use

Enrollment:	546
Study Start Date:	March 1998
Primary Completion Date:	October 2000 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Males or females between the ages of 18 and 70 with asthma

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00140946

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

No publications provided

Responsible Party:	Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
ClinicalTrials.gov Identifier:	NCT00140946 History of Changes
Other Study ID Numbers:	2005_057, MK0476-075
Study First Received:	August 30, 2005
Last Updated:	November 24, 2009
Health Authority:	Spain: Ministry of Health

Additional relevant MeSH terms:

Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Budesonide
Montelukast
Bronchodilator Agents
Autonomic Agents

Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Inflammatory Agents
Leukotriene Antagonists
Hormone Antagonists

ClinicalTrials.gov processed this record on February 09, 2012